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Liver Failure, AcuteHERCOLENCT03312036

HEpatic Regeneration With COupled Plasma Filtration and Adsorption for Liver Extracorporeal Detoxification

A study testing Coupled plasma filtration and adsorption (CPFA) in people with Liver Failure, Acute and Liver Failure, Acute on Chronic, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

CPFA is currently used in the treatment of severe sepsis with the intention of removing the proinflammatory mediators from the systemic circulation. Some evidence exists about the bilirubin adsorbing ability of the neutral styrenic resin which is part of the extracorporeal circuit of CPFA. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Coupled plasma filtration and adsorption (CPFA)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteItaly
Study dates
6 Jun 2013to 21 Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Acute liver failure
  • Acute on chronic liver failure
  • Bridge to liver transplantation

Who cannot join

  • acute hemorrhage
  • shock
  • respiratory failure
  • acute coronary syndrome
  • psychiatric illnesses

Trial locations and contacts

1 site in 1 country.

Italy1 site
  • Nephrology Dialysis and Renal Transplantation Unit, S.Orsola University Hospital

    Bologna

Other trials in Italy

About this study

CPFA is currently used in the treatment of severe sepsis with the intention of removing the proinflammatory mediators from the systemic circulation. Some evidence exists about the bilirubin adsorbing ability of the neutral styrenic resin which is part of the extracorporeal circuit of CPFA. The aim of this study is to assess efficacy and safety of CPFA in extracorporeal detoxification of liver toxins in patients affected by acute or acute-on-chronic liver failure.

Read the detailed description

CPFA allows an improvement of blood pressure and inflammatory response during sepsis and multiorgan failure. This extracorporeal detoxification system was developed to non-specifically remove larger mediators during systemic inflammation with an extracorporeal circuit consisting of a plasma filter, a resin cartridge and a high-flux dialyzer. At present it is performed with the use of a five-pump modular treatment consisting of a plasma filter and a following absorption on an unselective hydrophobic resin cartridge and a final passage of the reconstituted blood through a high permeability polyethersulfone haemofilter, in which convective exchanges may be applied in a postdilution mode. Ronco et al. in 2002 compared CPFA treatment to continuous veno-venous haemodiafiltration (CVVHDF) in 10 patients affected by septic shock. The patients underwent 10-hour length CPFA and an increase of arterial blood pressure and a significant reduction of norepinephrine dosage were observed in comparison to the arterial blood pressure and the norepinephrine dosage achieved with the CVVHDF treatment. Formica et al. in 2004 confirmed these results using 100 CPFA treatments in 12 patients affected by septic shock with or without acute kidney injury. Patient survival at 28 days was 90%, while survival of after 90 days was 70%. Mao et al. also compared CPFA with High Volume Hemofiltration and they showed that CPFA increased the ratio between anti-inflammatory and pro-inflammatory cytokines; CPFA enhanced Human Leucocyte Antigen (HLA) class II expression on monocytes and improved the leukocyte response to inflammation measuring leukocyte production of Tumor Necrosis Factor-alfa. Recently Livigni et al. on behalf of the Italian group for the evaluation of interventions in intensive care medicine carried out a randomised controlled trial enrolled 330 adult patients with septic shock, 192 were randomised to either have CPFA added to the standard care, or not. CPFA was to be performed daily for 5 days, lasting at least 10 h/day. The trial was stopped because nearly 50% of the patients could not achieve treatment completion due to technical reasons (primarily coagulation). The trial did observe that patients with the highest amounts of treated plasma appeared to have a survival benefit. The technique underwent further modifications to improve the technical aspects and anticoagulation and a new trial is now underway with a high dose of plasma > 0.18 litres/ kg/ day.

As to the hepatic toxin removal it depends on the ability of the detoxification system to extract albumin bound toxins by means of adsorption. The adsorption consists in the consolidation on the surface of a solid material of molecules floating in a fluid after matching the fluid with the solid. The consolidation is due to weak bounds as in the case of Van der Waals and hydrophobic bounds. The selectivity of adsorption occurs when albumin molecules easily pass throughout the sorbent while the sorbent draw the albumin carried toxins into the pores of the sorbent. The hepatic toxins often are hydrophobic and with molecular weight < 1,000 daltons (bilirubin = 406 daltons, cholic acid = 283 daltons, chenodeoxycholic acid = 272 daltons). The albumin structure consists in 3 domains, which allows a multi-binding protein transport. As to bilirubin, its protein binding is a physiological protective mechanism to prevent the free bilirubin diffusion and toxicity in human tissues. The amount of bilirubin production is about 300 gr/day. The molecule most tightly bound to albumin is non-conjugated bilirubin: the amount of non-conjugated bilirubin not bound to albumin is < 0.1%. Non-conjugated bilirubin is currently considered as "indirect" bilirubin because it gives an indirect reaction with standard diazo reagents. Conjugated bilirubin is also bound to albumin but with a reduced affinity. The albumin-bilirubin bond occurs by means of covalent or non-covalent strengths. The 2 bilirubin binding sites on albumin show different constant of association (Ka). The primary site has a high affinity, its Ka is 55-68 micromol/L and it can bind only 1 mole of bilirubin. The secondary site has a low affinity, its Ka is 4.4-5.0 micromol/L and it can bind more than 1 mole of bilirubin. A gap between 20 and 50 ångström between albumin and the sorbent is needed to move bilirubin from albumin to the sorbent.

The CPFA efficacy on bilirubin adsorption is based on hydrophobic polystyrene-divinylbenzene copolymer matrices of the resin cartridge that have mean pore sizes of 30 nanometres. Harm et al. reported that the hydrophobic polystyrene-divinylbenzene copolymer of CPFA resin cartridge (type B copolymer: mean diameter 128 micron, pore size 30 nanometres and surface area of 700 m2/gr of resin) binds higher amount of bilirubin than the amount of bilirubin bound with the other kinds of polystyrene-divinylbenzene copolymer matrices tested (type A copolymer: mean diameter 120 micron, pore size 15 nanometres and surface area of 900 m2/gr of resin; type C copolymer: mean diameter 37 micron, pore size 100 nanometres and surface area of 200 m2/gr of resin).

Few authors in vivo assessed the bilirubin adsorbing ability of the neutral styrenic resin of CPFA. Caroleo et al. reported the first case of hepatic toxins removal by means of CPFA in a patient affected by acute liver failure due to cardiogenic shock. Maggi et al. reported 2 further cases where bilirubin removal was obtained in 2 patients with delayed graft function after liver transplantation. The patients achieved a 40% bilirubin reduction after 3 treatments with CPFA lasting 3-hours each.

Being tested
Coupled plasma filtration and adsorption (CPFA)
Keywords
CPFA, Liver failure, Resin, detoxification
Medical subject headings
Liver Failure, Acute, Acute-On-Chronic Liver Failure, Liver Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Coupled plasma filtration and adsorption (CPFA)Device

    Patients affected by acute or acute on chronic liver failure are enrolled to undergo CPFA extracorporeal treatments and the standard medical therapy to recover their basal liver function or as a "bridge" to liver transplantation

Study groups in NCT03312036
Study groupRoleWhat they receive
CPFA PatientsExperimentalPatients affected by acute or acute on chronic liver failure who undergo Coupled plasma filtration and adsorption (CPFA) to recover their basal liver function or as a bridge to liver transplantation. The intervention is CPFA treatment which lasts 6 hour length. The intervention can be repeated for a maximum of 5 times.
Receives: Device: Coupled plasma filtration and adsorption (CPFA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The mortality reduction of patients with acute or acute on chronic liver failure;

    The measure is the overall survival of the patients after CPFA and standard medical therapy

    Measured: 1 year

Secondary outcomes (5)
  1. Efficacy of liver toxins detoxification

    The measures of efficacy consist in the evaluation bilirubin levels, biliary acids levels, ammonia levels and lactate levels

    Measured: 1 year.

  2. Improvement of hepatic encephalopathy

    The measure of hepatic encephalopathy is assessed by means of the West Haven Criteria

    Measured: 1 year

  3. Improvement of the arterial blood pressure of the patients

    Measuring arterial blood pressure (mmHg) on starting CPFA, during the CPFA treatment and at CPFA end.

    Measured: 1 year

  4. Biocompatibility of CPFA

    Blood leukocytes, platelets, Hemoglobin are assessed before and after each CPFA treatment

    Measured: 1 year

  5. Cytokines clearance during CPFA

    Interleukin-6, Tumor Necrosis Factor alfa, Interleukin-10, Hepatocyte growth factor are assessed before and after each CPFA treatment

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2017
  2. Study start6 Jun 2013
  3. Primary completion21 Dec 2018
  4. Study completion21 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03312036
Sponsor's protocol ID
87/2012/O/Disp
Acronym
HERCOLE
Status last verified
Mar 2021
First submitted
28 Sep 2017
Last updated
17 Mar 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ronco C, Brendolan A, d'Intini V, Ricci Z, Wratten ML, Bellomo R. Coupled plasma filtration adsorption: rationale, technical development and early clinical experience. Blood Purif. 2003;21(6):409-16. doi: 10.1159/000073444.

    PubMed 14586184
  • Tetta C, Cavaillon JM, Schulze M, Ronco C, Ghezzi PM, Camussi G, Serra AM, Curti F, Lonnemann G. Removal of cytokines and activated complement components in an experimental model of continuous plasma filtration coupled with sorbent adsorption. Nephrol Dial Transplant. 1998 Jun;13(6):1458-64. doi: 10.1093/ndt/13.6.1458.

    PubMed 9641176
  • Cole L, Bellomo R, Davenport P, Tipping P, Uchino S, Tetta C, Ronco C. The effect of coupled haemofiltration and adsorption on inflammatory cytokines in an ex vivo model. Nephrol Dial Transplant. 2002 Nov;17(11):1950-6. doi: 10.1093/ndt/17.11.1950.

    PubMed 12401852
  • Ronco C, Brendolan A, Lonnemann G, Bellomo R, Piccinni P, Digito A, Dan M, Irone M, La Greca G, Inguaggiato P, Maggiore U, De Nitti C, Wratten ML, Ricci Z, Tetta C. A pilot study of coupled plasma filtration with adsorption in septic shock. Crit Care Med. 2002 Jun;30(6):1250-5. doi: 10.1097/00003246-200206000-00015.

    PubMed 12072677
  • Formica M, Olivieri C, Livigni S, Cesano G, Vallero A, Maio M, Tetta C. Hemodynamic response to coupled plasmafiltration-adsorption in human septic shock. Intensive Care Med. 2003 May;29(5):703-8. doi: 10.1007/s00134-003-1724-0. Epub 2003 Mar 29.

    PubMed 12665998
  • Mariano F, Tetta C, Stella M, Biolino P, Miletto A, Triolo G. Regional citrate anticoagulation in critically ill patients treated with plasma filtration and adsorption. Blood Purif. 2004;22(3):313-9. doi: 10.1159/000078788.

    PubMed 15256798
  • Lentini P, Cruz D, Nalesso F, de Cal M, Bobek I, Garzotto F, Zanella M, Brendolan A, Piccinni P, Ronco C. [A pilot study comparing pulse high volume hemofiltration (pHVHF) and coupled plasma filtration adsorption (CPFA) in septic shock patients]. G Ital Nefrol. 2009 Nov-Dec;26(6):695-703. Italian.

    PubMed 19918752
  • Mao HJ, Yu S, Yu XB, Zhang B, Zhang L, Xu XR, Wang XY, Xing CY. Effects of coupled plasma filtration adsorption on immune function of patients with multiple organ dysfunction syndrome. Int J Artif Organs. 2009 Jan;32(1):31-8. doi: 10.1177/039139880903200104.

    PubMed 19241361
  • Livigni S, Bertolini G, Rossi C, Ferrari F, Giardino M, Pozzato M, Remuzzi G; GiViTI: Gruppo Italiano per la Valutazione degli Interventi in Terapia Intensiva (Italian Group for the Evaluation of Interventions in Intensive Care Medicine) is an independent collaboration network of Italian Intensive Care units. Efficacy of coupled plasma filtration adsorption (CPFA) in patients with septic shock: a multicenter randomised controlled clinical trial. BMJ Open. 2014 Jan 8;4(1):e003536. doi: 10.1136/bmjopen-2013-003536.

    PubMed 24401721
  • Hughes RD. Review of methods to remove protein-bound substances in liver failure. Int J Artif Organs. 2002 Oct;25(10):911-7. doi: 10.1177/039139880202501003.

    PubMed 12456030
  • Weiss JS, Gautam A, Lauff JJ, Sundberg MW, Jatlow P, Boyer JL, Seligson D. The clinical importance of a protein-bound fraction of serum bilirubin in patients with hyperbilirubinemia. N Engl J Med. 1983 Jul 21;309(3):147-50. doi: 10.1056/NEJM198307213090305.

    PubMed 6866015
  • Gong D, Cruz D, Ronco C. Depurative capacity of molecular adsorbent recycling system (MARS): A focus on bilirubin removal. Int J Artif Organs. 2008 Oct;31(10):875-81. doi: 10.1177/039139880803101003.

    PubMed 19009505
  • Harm S, Falkenhagen D, Hartmann J. Pore size--a key property for selective toxin removal in blood purification. Int J Artif Organs. 2014 Sep;37(9):668-78. doi: 10.5301/ijao.5000354. Epub 2014 Sep 23.

    PubMed 25262632
  • Caroleo S, Rubino AS, Tropea F, Bruno O, Vuoto D, Amantea B, Renzulli A. Coupled plasma filtration adsorption reduces serum bilirubine in a case of acute hypoxic hepatitis secondary to cardiogenic shock. Int J Artif Organs. 2010 Oct;33(10):749-52.

    PubMed 21058270
  • Maggi U, Nita G, Gatti S, Antonelli B, Paolo R, Como G, Messa P, Rossi G. Hyperbilirubinemia after liver transplantation: the role of coupled plasma filtration adsorption. Transplant Proc. 2013 Sep;45(7):2715-7. doi: 10.1016/j.transproceed.2013.07.019.

    PubMed 24034030

Questions about this trial

What is this clinical trial studying?

A study testing Coupled plasma filtration and adsorption (CPFA) in people with Liver Failure, Acute and Liver Failure, Acute on Chronic, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The mortality reduction of patients with acute or acute on chronic liver failure; (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03312036, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.

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